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Compressed chewing gum tablet
8603440 Compressed chewing gum tablet
Patent Drawings:

Inventor: Andersen, et al.
Date Issued: December 10, 2013
Application:
Filed:
Inventors:
Assignee:
Primary Examiner: Packard; Benjamin
Assistant Examiner:
Attorney Or Agent: St. Onge Steward Johnston & Reens LLC
U.S. Class: 424/48; 514/343
Field Of Search: ;426/3; ;424/48; ;514/343
International Class: A61K 9/68; A61K 31/44; A01N 43/40
U.S Patent Documents:
Foreign Patent Documents: 2523510; 0711506; 1474993; 1554935; 1693086; 1545234; 0025598; 02102357; 2004004480; 2004028270; 2004032644; 2004098305; 2006000232; 2006002622; 2006079343; 2006127618
Other References: FDA, Comparative Chenmical Analysis of Different Lots of Ariva, 2002, pp. 1-4,www.fda.gov/ohrms/DOCKETS/daily/02/Nov02/111502/02p-0075-sup0002-02-- attach-a-vol2.pdf. cited by examiner.
Food and Drug Administration, CFR, Title 21, Section 172,615, the Masticatory Substances, Synthetic; Apr. 1, 2005 edition; 2 pages. cited by applicant.
International Preliminary Report on Patentability and Written Opinion of the International Searching Authority; PCT/DK2007/000563; Jun. 22, 2010; 6 pages. cited by applicant.
International Search Report; PCT/DK2007/000563; Sep. 24, 2008; 3 pages. cited by applicant.
H.P. Fiedler, Lexikon der Hilfstoffe fur Pharmacie, Kosmetik und Angrenzende Gebiete, pp. 63-64 (1981). cited by applicant.









Abstract: A compressed chewing gum tablet includes one or more pharmaceutically active ingredients and one or more enhancers, wherein the chewing gum tablet includes at least one chewing gum module including a chewing gum composition, and wherein the chewing gum composition includes chewing gum granules containing gum base, and wherein the enhancers are at least partly contained within at least a part of the chewing gum granules.
Claim: What is claimed is:

1. Compressed chewing gum tablet comprising one or more pharmaceutically active ingredients and one or more enhancers, wherein the chewing gum tablet comprises at least onechewing gum module comprising a chewing gum composition, and wherein the chewing gum composition comprises chewing gum granules containing gum base, wherein said enhancers are at least partly contained within at least a part of said chewing gum granules,wherein the one or more enhancers comprise a pH control agent, wherein said pH control agent facilitates that pH as measured during chewing in a mastication device is kept above the highest pKa value of the pharmaceutically active ingredient for at leasta part of a chewing period, and wherein the one or more pharmaceutically active ingredients comprise nicotine in the form of nicotine polacrilex.

2. Compressed chewing gum tablet according to claim 1, wherein said compressed chewing gum tablet comprises at least two individual coherent compressed modules.

3. Compressed chewing gum tablet according to claim 1, wherein the compressed chewing gum tablet comprises one or more gum base free modules.

4. Compressed chewing gum tablet according to claim 1, wherein the modules are layers.

5. Compressed chewing gum tablet according to claim 1, wherein at least one of the pharmaceutically active ingredients is separated from at least one of the enhancers by location in different modules.

6. Compressed chewing gum tablet according to claim 1, wherein at least a part of the pharmaceutically ingredients are incorporated in at least a part of the chewing gum granules.

7. Compressed chewing gum tablet according to claim 1, wherein at least a part of the pharmaceutically active ingredients are adhered to at least one of bulk sweetener particles and chewing gum granules by way of flavor.

8. Compressed chewing gum tablet according to claim 1, wherein at least a part of the pharmaceutically active ingredients are adhered to dry-binder particles, are interspersed between said chewing gum granules, or are both adhered to dry-binderparticles and interspersed between said chewing gum granules.

9. Compressed chewing gum tablet according to claim 1, wherein at least a part of said enhancers are at least one of interspersed between, and incorporated in, said chewing gum granules.

10. Compressed chewing gum tablet according to claim 1, wherein at least a part of the pH control agent is incorporated in the chewing gum granules and at least a part of the pH control agent is part of the chewing gum composition as a powder.

11. Compressed chewing gum tablet according to claim 1, wherein said pharmaceutically active ingredients are at least partly contained within at least a part of said chewing gum granules.

12. Compressed chewing gum tablet according to claim 1, wherein at least 50% of said chewing gum granules has an average diameter of between 100 .mu.m and 1600 .mu.m.

13. Compressed chewing gum tablet according to claim 1, wherein the chewing gum granules in the chewing gum composition comprising pharmaceutically active ingredients have average particle sizes below 1500 .mu.m.

14. Compressed chewing gum tablet according to claim 1, wherein at least a part of said one or more pharmaceutically active ingredients are mixed into said chewing gum mixture prior to granulation.

15. Compressed chewing gum tablet according to claim 1, wherein at least a part of the pharmaceutically active ingredients are adhered to bulk sweetener particles by way of flavor.

16. Compressed chewing gum tablet according to claim 1, wherein at least a part of the pharmaceutically active ingredients are adhered to dry-binder particles.

17. Compressed chewing gum tablet according to claim 1, wherein the chewing gum composition is prepared by spraying one or more flavor materials onto particles of bulk sweetener and letting particles of the pharmaceutically active ingredientsadhere thereto.

18. Compressed chewing gum tablet according to claim 1, wherein the chewing gum composition is prepared by spraying one or more flavor materials onto chewing gum granules and particles of bulk sweetener and letting particles of thepharmaceutically active ingredients adhere thereto.

19. Compressed chewing gum tablet according to claim 1, wherein an amount of dry-binder is used to adhere active pharmaceutical ingredients to bulk sweetener.

20. Compressed chewing gum tablet according to claim 1, wherein said compressed chewing gum tablet comprises at least three individual coherent compressed modules.
Description:
 
 
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